Evaluation of Nebulization and Positive Expiratory Pressure Combination

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02535130
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficiency of nebulization and positive expiratory pressure combination

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis; Healthy Subjects	Device: Positive expiratory pressure; Drug: amikacine nebulization	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Anticipated Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nebulization combined to positive expiratory pressure Experimental arm	Device: Positive expiratory pressure; Drug: amikacine nebulization
Active Comparator: Nebulization Control arm	Drug: amikacine nebulization

Outcome Measures

Primary Outcome Measures

1. Urinary excretion of amikacin [24 hours after the nebulization]

   Pharmacokinetic study of the urinary excretion of amikacin after nebulization

Secondary Outcome Measures

1. breathing pattern [participants will be recorded for the duration of the nebulization, an expected average of 15 minutes]

   recoding of frequency and tidal volume during the nebulization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Stable cystic fibrosis patients older than 16 y.o.

• Healthy subjects

Exclusion Criteria:

• Kidney failure

• No pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques universitaires Saint-Luc	Brussels		Belgium	1200

Sponsors and Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT02535130
• Other Study ID Numbers: NebuPEP
• First Posted: Aug 28, 2015
• Last Update Posted: Aug 17, 2016
• Last Verified: Aug 1, 2016

• Additional relevant MeSH terms: Cystic Fibrosis; Amikacin

Study Results

No Results Posted as of Aug 17, 2016